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Effect of Bilateral Rectointercostal Fascial Plane Block on Postoperative Pain After Laparoscopic Sleeve Gastrectomy

NCT07253610 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-12-29

No results posted yet for this study

Summary

This randomized controlled study aims to evaluate the effectiveness of the bilateral rectointercostal fascial plane (RIB) block for postoperative pain management in patients undergoing laparoscopic sleeve gastrectomy. The study compares RIB block combined with standard general anesthesia to standard intravenous patient-controlled analgesia alone. The primary outcome is total opioid consumption within the first 24 postoperative hours, while secondary outcomes include pain scores, patient satisfaction, postoperative nausea and vomiting, and block-related complications.

Conditions

  • Obesity, Morbid
  • Pain, Postoperative
  • Laparoscopic Sleeve Gastrectomy (LSG)
  • Opioid Use

Interventions

OTHER

Bilateral Rectointercostal Fascial Plane Block

Under ultrasound guidance, 30 mL of local anesthetic will be injected bilaterally between the rectus abdominis and intercostal muscles at the level of the 6th-7th costal cartilages to achieve rectointercostal fascial plane block prior to general anesthesia.

OTHER

Intravenous Patient-Controlled Analgesia (IV PCA) with Morphine

For all groups, intravenous patient-controlled analgesia (IV PCA) will be initiated in the post-anesthesia care unit (PACU) using a BodyGuard 575 Pain Manager (UK). The total morphine consumption during the first 24 hours postoperatively will be recorded. The PCA regimen will be standardized as follows: no basal infusion, a 1 mg morphine bolus dose, a lock-out interval of 15 minutes, and a maximum dose limit of 10 mg within 4 hours. Approximately 45 minutes before the end of surgery, patients will receive 1 g paracetamol, 20 mg tenoxicam, and 3.5 mg morphine intravenously. Postoperatively, paracetamol will be administered every 8 hours and tenoxicam every 12 hours. This postoperative pain management strategy reflects the standard protocol routinely used in our clinic.

Sponsors & Collaborators

  • Samsun University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2025-12-21
Completion
2025-12-21

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07253610 on ClinicalTrials.gov